Impingement detection for implantable medical devices

ABSTRACT

In some examples, a system may be used for delivering cardiac therapy or cardiac sensing. The system may include an in implantable medical device including a housing configured to be implanted on or within a heart of a patient, a fixation element configured to attach the housing to the heart; and a sensor configured to produce a signal that indicates motion of the implantable medical device. Processing circuitry may be configured to identify one or more impingements between the housing and another structure, such as a tissue of the heart, based on the signal from the sensor and provide an indication of the one or more impingements to a user.

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/639,376, entitled, “IMPINGEMENT DETECTION FORIMPLANTABLE MEDICAL DEVICES,” and filed on Mar. 6, 2018, the entirecontent of which is incorporated by reference.

TECHNICAL FIELD

The disclosure relates to medical devices, and more particularly medicaldevices that are configured for implantation on or within the heart.

BACKGROUND

Some types of implantable medical devices, such as cardiac pacemakers orimplantable cardioverter defibrillators, monitor physiologicalconditions and provide therapeutic electrical signals to a heart of apatient, such as bradycardia pacing, cardiac resynchronization therapy(CRT), anti-tachycardia pacing (ATP), and cardioversion/defibrillationshocks. Medical device technology advancement has led toward smaller andsmaller implantable devices. Recently, cardiac pacemakers have beenintroduced which may be implanted directly in a heart chamber. In someexamples, such pacemakers may be leadless and delivered into the heartchamber using a catheter. Such miniaturized pacemakers may be referredto as intracardiac pacing devices (PDs), although they may beepicardially or extracardially implanted in some examples. Anintracardiac PD may be configured to deliver CRT, e.g., as part of asystem with one or more other devices.

SUMMARY

Depending upon the location where it is implanted, an intracardiac PDmay impinge on, e.g., collide or otherwise mechanically interact with,cardiac structures, such as papillary muscles, cordae, valve structures,or ventricular endocardium, or other non-cardiac structures, such asother implantable medical devices (IMDs), a component of another IMD, orsome other non-anatomical structure. In some cases, collisions canresult in mechanical damage to the PD or cardiac structures, scar tissueformation, or formation of inflammatory vegetations that can embolize orimpede blood flow. In some cases, collisions may impede the performanceof one or more sensors of the PD, such as by distorting an accelerometeror other motion sensor signal, which can be used by the PD to trackcardiac contractility, patient activity, or the effectiveness of pacingin capturing the heart, as examples. The artifact caused by theimpingement may interfere with these uses of the accelerometer. Ingeneral, this disclosure is directed to techniques detecting impingementof an IMD, e.g., a PD, with cardiac tissue or other structures.Impingement detection is generally described as occurring duringimplantation of the IMD but may occur at any time after implantation.

More particularly, the techniques include detecting impingements basedon a signal from a sensor that indicates motion of the IMD. The sensormay be a multi-axis accelerometer located within a housing of the IMD.The signal may vary with the mechanical cardiac cycle, and processingcircuitry may identify impingements based on characteristics of thesignal during a cardiac cycle, such as a frequency exceeding a thresholdand/or a magnitude of motion orthogonal to a primary axis of systolicmotion exceeding a threshold. By acquiring and analyzing sensor signals,the processing circuitry may determine whether impingement is occurringbetween the device and other structures during the cardiac cycle. Ifimpingement is occurring, the processing circuitry may inform a user,such as the IMD implanter or other medical professional, of theimpingement(s) or impingement severity, which may, for example,encourage the user to seek a different implant site based on anevaluation of the impingement.

In one example, a system for at least one of delivering cardiac therapyor cardiac sensing comprises an implantable medical device including ahousing configured for implantation at least one of on or within a heartof a patient, at least one fixation element configured to attach thehousing to the heart, and a sensor configured to produce a signal thatindicates motion of the implantable medical device. The system furthercomprises processing circuitry configured to identify one or moreimpingements between the housing and another structure based on thesignal from the sensor and provide an indication of the one or moreimpingements to a user.

Another example is a method for evaluating implantation of animplantable medical device configured for at least one of deliveringcardiac therapy or cardiac sensing. The method comprises producing, by asensor, a signal that is indicative of a motion of the implantablemedical device and identifying one or more impingements between ahousing of the implantable medical device and another structure based onthe signal from the sensor.

Other examples include a system for evaluating implantation of animplantable medical device configured for at least one of deliveringcardiac therapy or cardiac sensing, wherein the implantable medicaldevice is attached by a fixation element to a heart of a patient, thesystem comprising means for producing, by a sensor, a signal that isindicative of a motion of the implantable medical device and means foridentifying one or more impingements between a housing of theimplantable medical device and another structure based on the signalfrom the sensor.

Other examples include a computer-readable storage medium comprisinginstructions that, when executed by processing circuitry of a medicaldevice system for evaluating implantation of an implantable medicaldevice configured for at least one of delivering cardiac therapy orcardiac sensing, wherein the implantable medical device is attached by afixation element to a heart of a patient, cause the processing circuitryto produce, by a sensor, a signal that is indicative of a motion of theimplantable medical device and identify one or more impingements betweena housing of the implantable medical device and another structure basedon the signal from the sensor.

Other examples include a system for at least one of delivering cardiactherapy or cardiac sensing comprises an implantable medical deviceincluding a housing configured for implantation at least one of on orwithin a heart of a patient, at least one fixation element configured toattach the housing to the heart, a sensor configured to produce a signalthat indicates motion of the implantable medical device, a plurality ofelectrodes, and signal generation circuitry within the housing, thesignal generation circuitry configured to deliver cardiac pacing via theplurality of electrodes. The system further comprises processingcircuitry configured to identify a heartbeat, identify one or moreimpingements between the housing and another structure based on thesignal from the sensor, identify one of the impingements during theheartbeat, and provide an indication of the one or more impingements toa user, wherein the processing circuitry comprises processing circuitryof the implantable medical device within the housing configured tocontrol the delivery of pacing by the signal generation circuitry, andwherein the housing is configured for implantation within the leftventricle of the heart.

This summary is intended to provide an overview of the subject matterdescribed in this disclosure. It is not intended to provide an exclusiveor exhaustive explanation of the methods and systems described in detailwithin the accompanying drawings and description below. The details ofone or more aspects of the disclosure are set forth in the accompanyingdrawings and the description below.

BRIEF DESCRIPTION OF DRAWINGS

The details of one or more examples of this disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of this disclosure will be apparent from thedescription and drawings, and from the claims.

FIG. 1A is a conceptual diagram illustrating an example front view of apatient implanted with an example medical device system that includes anextracardiovascular ICD (EV-ICD) system and a pacing device (PD) that isimplanted within a cardiac chamber of the patient in accordance with oneor more aspects of this disclosure.

FIG. 1B is a conceptual diagram illustrating an example side view of apatient implanted with the example medical device system of FIG. 1A, inaccordance with one or more aspects of this disclosure.

FIG. 1C is a conceptual diagram illustrating an example transverse viewof a patient implanted with the example medical device system of FIG.1A, in accordance with one or more aspects of this disclosure.

FIG. 2 is a conceptual diagram illustrating an example front view of apatient implanted with another example medical device system thatincludes an insertable cardiac monitoring (ICM) device that is insertedsubcutaneously or substernally in the patient, and a PD implanted withina cardiac chamber of the patient, in accordance with one or more aspectsof this disclosure.

FIG. 3 is a conceptual drawing illustrating an example configuration ofthe ICM device illustrated in FIG. 2, in accordance with one or moreaspects of this disclosure.

FIG. 4 is a conceptual drawing illustrating an example configuration ofa PD in accordance with one or more aspects of this disclosure.

FIG. 5 is a functional block diagram illustrating an exampleconfiguration of an IMD in accordance with one or more aspects of thisdisclosure.

FIG. 6 is a functional block diagram illustrating an exampleconfiguration of a PD in accordance with one or more aspects of thisdisclosure.

FIG. 7 is a functional block diagram illustrating an exampleconfiguration of the external device in FIG. 1A, in accordance with oneor more aspects of this disclosure.

FIG. 8 is a block diagram illustrating a system that includes anexternal device, such as a server, and one or more computing devicesthat are coupled to an IMD, PD, and external device via a network, inaccordance with one or more aspects of this disclosure.

FIGS. 9A-H illustrate techniques for securing an IMD to a patienttissue, in accordance with one or more aspects of this disclosure.

FIG. 10 is a flow diagram illustrating an example process of attachingan IMD to a patient tissue while monitoring impingement, in accordancewith one or more aspects of this disclosure.

FIG. 11 is a flow diagram illustrating an example process fordetermining whether impingement is occurring based on an evaluation ofthe features of a motion signal during a cardiac beat, in accordancewith one or more aspects of this disclosure.

FIG. 12A is a plot illustrating motion of an IMD during cardiaccontraction, in accordance with one or more aspects of this disclosure.

FIG. 12B is a plot illustrating the motion of the IMD with the axestransformed such that the primary axis of motion during systole is outof the plane of the plot and the motion orthogonal to the primary axisis emphasized, in accordance with one or more aspects of thisdisclosure.

FIGS. 13A and 13B are plots of motion sensor data illustrating motion ofthe IMD, including the frequency of the motion during systole, inaccordance with one or more aspects of this disclosure.

FIGS. 13C and 13D are plots of motion sensor data with axes transformedillustrating motion of the IMD orthogonal to the primary systolic axisduring cardiac contraction, in accordance with one or more aspects ofthis disclosure.

FIG. 14 is a conceptual plot of motion of the IMD during cardiaccontraction illustrating example features of the motion signal, inaccordance with one or more aspects of this disclosure.

DETAILED DESCRIPTION

As described above, in general, this disclosure describes exampletechniques related to detecting impingement of an IMD at the time ofimplant or any time thereafter, e.g., using an IMD such as anintracardiac PD. The introduction of such PDs, and the resultingelimination of the need for transvenous intracardiac leads, providesseveral advantages. For example, complications due to infectionassociated with a lead extending from a subcutaneous pacemaker pockettransvenously into the heart may be eliminated. Other complications,such as “twiddler's syndrome,” lead fracture, or poor connection of thelead to the pacemaker are eliminated in the use of an intracardiac PD.

On the other hand, the location of the PD within the heart may impingeon cardiac structures. With each beat of the heart, the intracardiac PDmay collide with structures such as papillary muscles, cordae, valvestructures, or ventricular endocardium. The intracardiac PD mayadditionally or alternatively collide with other structures, which mayor may not be anatomical. Such structures may include another PD orother IMD, or component thereof, such as a fixation tine or otherfixation element of another PD, or a lead coupled to another IMD. Insome examples, one or more fixation elements of the PD may be broken,and the PD may impinge with a separated portion of a broken fixationelement.

As described in greater detail herein, an IMD, such as a PD, or one ormore other components of a medical device system including the IMD, maydetect whether the IMD is impinging with another structure. In someexamples, the detection of impingements may take place during implant ofan IMD. In some examples, the detection of impingements may additionallyor alternatively occur after implant including, for example,periodically, such as once a minute, once an hour, or once every 24hours, although other frequencies may also be used.

FIGS. 1A-1C are conceptual diagrams illustrating various views of anexample cardiac medical device system 8A implanted within a patient 14.Components with like numbers in FIGS. 1A-1C may be similarly configuredand may provide similar functionality. Medical device system 8A asillustrated in FIGS. 1A-1C may be configured to perform one or more ofthe techniques described herein with respect to detecting impingement ofan IMD, such as a PD, with another structure, such as cardiac tissue.

FIG. 1A is a conceptual diagram illustrating an example front view of apatient implanted with an example cardiac medical device system 8A thatincludes an extracardiovascular implantable cardioverter defibrillator(ICD) system 4A, and a pacing device (PD) 12A that is implanted within acardiac chamber of patient 14 in accordance with one or more aspects ofthis disclosure. PD 12A may be, for example, an implantable leadlesspacing device (e.g., a pacemaker) that provides electrical signals toheart 16A via electrodes carried on the housing of PD 12A.

With respect to FIGS. 1A-1C, and elsewhere herein, PD 12A is generallydescribed as being attached within a chamber of heart 16A. That is, PD12A is described in various portions of this disclosure as anintracardiac pacing device. In other examples that are consistent withaspects of this disclosure, PD 12A may be attached to an externalsurface of heart 16A, such that PD 12A is disposed outside of heart 16Abut may pace a desired chamber. In one example, PD 12A is attached to anexternal surface of heart 16A, and one or more components of PD 12A maybe in contact with the epicardium of heart 16A. Although PD 12A isgenerally described as a pacing device for intracardiac implantation, PD12A may alternatively be configured to attach to an external surface ofheart 16A and operate as an extracardiac pacing device.

In one example, PD 12A may be implanted within the left or rightventricle of a heart to sense electrical activity of a heart, detectimpingement, and/or deliver electrical stimulation to a heart. PD 12A isschematically shown in FIG. 1A attached to a wall of the left ventriclevia one or more fixation elements (e.g., tines, helix, etc.) thatpenetrate the tissue. These fixation elements may secure PD 12A to thecardiac tissue and retain an electrode (e.g., a cathode or an anode) incontact with the cardiac tissue. PD 12A (and PD 12B in FIG. 2) may beimplanted at or proximate to the apex of the heart. In other examples, aPD may be implanted at other left-ventricular locations, e.g., on thefree-wall or septum.

PD 12A may also include one or more motion sensors (e.g.,accelerometers, gyroscopes, or electrical or magnetic field sensors). Aswill be described in greater detail below, processing circuitry ofsystem 8A, e.g., of PD 12A, may be configured to detect and/or confirmimpingement of PD 12A by cardiac tissue or another structure from themotion of PD 12A as indicated by the signal generated by the one or moremotion sensors. Collisions between cardiac tissue and PD 12A areexamples of impingements. Features of the motion signal that mayindicate impingement include, as examples, the presence of a frequencyin the signal that is higher than those typically associated withcardiac contraction, and instead indicates collision or otherimpingement, a velocity of the motion greater than that typicallyassociated with cardiac contraction, or a greater than expected amountof motion occurring in a direction other than the primary direction ofmotion during a cardiac contraction. In some examples, the features ofthe motion signal that indicate impingement may vary depending on theposture of the patient, which can be derived from the one or more motionsensors. Consequently, processing circuitry may adjust the motionsignal, or thresholds or other criteria applied to the motion signal,based on the posture of the patient to compensate for the posture-basedvariation of the features and allow effective detection of impingementin a variety of postures.

In examples in which PD 12A is implanted at or near the apex of heart16, the motion sensor may be correspondingly located at or near theapex. Since PD 12A includes two or more electrodes carried on theexterior housing of PD 12A, no other leads or structures need to residein other chambers of heart 16. However, in other examples, medicaldevice system 8A may include additional PDs within respective chambersof heart 16 (e.g., left atrium, right atrium), or coupled by leads toelectrodes in such chambers of heart.

ICD system 4A includes ICD 10A that is connected to at least oneimplantable cardiac defibrillation lead 18A (hereinafter,“defibrillation lead 18A”). ICD 10A is configured to deliver high-energycardioversion or defibrillation shocks to heart 16A of patient 14 inresponse to atrial fibrillation or ventricular fibrillation beingdetected. Cardioversion shocks are typically delivered in synchrony witha detected R-wave, when fibrillation detection criteria are met.Defibrillation shocks are typically delivered when fibrillation criteriaare met, and the R-wave cannot be discerned from signals sensed by ICD10A.

ICD 10A of FIG. 1A may be implanted subcutaneously or submuscularly onthe left side of patient 14 above the ribcage. FIG. 1C is a conceptualdiagram illustrating an example transverse view of a patient implantedwith the example medical device system of FIG. 1A, in accordance withone or more aspects of this disclosure. Defibrillation lead 18A of FIG.1A may be implanted at least partially in a substernal location in FIG.1A, e.g., between the ribcage and/or sternum 22 and heart. In one suchconfiguration, a proximal portion of defibrillation lead 18A extendssubcutaneously from ICD 10A toward the sternum, and a distal portion oflead 18A extends under or below the sternum 22 in the anteriormediastinum 36 (see FIG. 1C). The anterior mediastinum 36 is boundedlaterally by the pleurae 39 (see FIG. 1C), posteriorly by thepericardium, and anteriorly by the sternum 22. In some instances, theanterior wall of the anterior mediastinum 36 may also be formed by thetransversus thoracis and one or more costal cartilages. The anteriormediastinum 36 includes a quantity of loose connective tissue (such asareolar tissue), some lymph vessels, lymph glands, substernalmusculature (e.g., transverse thoracic muscle), branches of the internalthoracic artery, and the internal thoracic vein. In one example, thedistal portion of defibrillation lead 18A extends along the posteriorside of the sternum 22 substantially within the loose connective tissueand/or substernal musculature of anterior mediastinum 36. Defibrillationlead 18A may be at least partially implanted in other intrathoraciclocations, e.g., other non-vascular, extra-pericardial locations,including the gap, tissue, or other anatomical features around theperimeter of and adjacent to, but not attached to, the pericardium orother portion of heart 16A and not above the sternum 22 or ribcage.

In other examples, defibrillation lead 18A may be implanted at otherextracardiovascular locations. For example, defibrillation lead 18A mayextend subcutaneously above the ribcage from ICD 10A toward a center ofthe torso of patient 14, bend or turn near the center of the torso, andextend subcutaneously superior above the ribcage and/or sternum 22, likethat shown in FIG. 1A. Defibrillation lead 18A may be offset laterallyto the left or the right of the sternum 22 or located over the sternum22. Defibrillation lead 18A may extend substantially parallel to thesternum 22 or be angled lateral from the sternum 22 at either theproximal or distal end. In another example, defibrillation lead 18Aand/or a pacing lead or sensing lead may be implanted within thepericardial sac of heart 16A, within the pericardium of heart 16A,epicardially with respect to heart 16A, or at another location.

Defibrillation lead 18A of FIG. 1A may include an insulative lead bodyhaving a proximal end that includes a connector configured to beconnected to ICD 10A and a distal portion that includes one or moreelectrodes. Defibrillation lead 18A may also include one or moreconductors that form an electrically conductive path within the leadbody and interconnect the electrical connector and respective ones ofthe electrodes.

Defibrillation lead 18A of FIG. 1A includes a defibrillation electrodethat, in the illustrated example, includes two sections or segments 20Aand 20B. Segments 20A and 20B are collectively (or alternatively)referred to herein as “defibrillation electrodes 20.” Defibrillationelectrodes 20 of FIG. 1A are positioned toward the distal portion ofdefibrillation lead 18A, e.g., toward the portion of defibrillation lead18A extending along sternum 22 of patient 14. Defibrillation lead 18A ofFIG. 1A is placed below and/or along sternum 22 such that a therapyvector between defibrillation electrodes 20A or 20B and a housingelectrode formed by ICD 10A or on ICD 10A (or other second electrode ofthe therapy vector) is substantially across a ventricle of heart 16A.The therapy vector may, in one example, be viewed as a line that extendsfrom a point on defibrillation electrodes 20 (e.g., a center of one ofthe defibrillation electrode sections 20A or 20B) to a point on thehousing electrode of ICD 10A. Each of defibrillation electrodes 20 ofFIG. 1A may, in one example, be an elongated coil electrode. In someexamples, a defibrillation lead may include more or fewer than the twodefibrillation electrodes 20 in the illustrated example ofdefibrillation lead 18A, such as a single coil defibrillation electrode20.

FIG. 1B is a conceptual diagram illustrating an example side view of apatient implanted with the example medical device system of FIG. 1A, inaccordance with one or more aspects of this disclosure. Defibrillationlead 18A may also include one or more sensing electrodes, such assensing electrodes 22A and 22B, located along the distal portion ofdefibrillation lead 18A. In the example illustrated in FIGS. 1A and 1B,sensing electrodes 22A and 22B are separated from one another bydefibrillation electrode 20A. In other examples, however, sensingelectrodes 22A and 22B may be both distal of defibrillation electrodes20, or both proximal of defibrillation electrodes 20. In other examples,defibrillation lead 18A may include a greater number or a fewer numberof electrodes at various locations proximal and/or distal todefibrillation electrodes 20. In these and/or other examples, ICD 10Amay include one or more electrodes on another lead (not shown in FIGS.1A-1C).

ICD system 4A may sense electrical signals via one or more sensingvectors that include combinations of electrodes 22A and 22B and thehousing electrode of ICD 10A. For example, ICD 10A may obtain electricalsignals that are sensed using a sensing vector between sensingelectrodes 22A and 22B, obtain electrical signals sensed using a sensingvector between sensing electrode 22B and the conductive housingelectrode of ICD 10A, obtain electrical signals sensed using a sensingvector between sensing electrode 22A and the conductive housingelectrode of ICD 10A, or a combination thereof. In some instances, ICD10A may sense cardiac electrical signals using a sensing vector thatincludes one of the defibrillation electrode sections 20A and 20B andone of sensing electrodes 22A and 22B or the housing electrode of ICD10A.

The sensed electrical intrinsic signals include electrical signals thatare generated by cardiac muscle and are indicative of depolarizationsand repolarizations of heart 16A at various times during the cardiaccycle. The sensed electrical signals may also include electricalsignals, e.g., pacing pulses, generated by PD 12A and delivered to heart16A. ICD 10A analyzes the electrical signals sensed by the one or moresensing vectors to detect tachyarrhythmia, such as atrial tachycardia,atrial fibrillation, ventricular tachycardia, or ventricularfibrillation. In response to detecting the tachyarrhythmia, e.g., aventricular fibrillation, ICD 10A may begin to charge a storage element,such as a bank of one or more capacitors. Upon determining that thestorage element is sufficiently charged, ICD 10A may deliver one or moredefibrillation pulses to certain chamber(s) of heart 16A viadefibrillation electrodes 20 of defibrillation lead 18A, if ICD 10Adetermines that the tachyarrhythmia is still present.

In the example of FIG. 1A, PD 12A is implanted within the left ventricleof heart 16A, to provide pacing pulses to the left ventricle, e.g., forCRT. While illustrated as being implanted within the left ventricle asan example, it will be appreciated that PD 12A may be implanted atdifferent positions as well. For instance, PD 12A may be implantedepicardially. That is, in accordance with epicardial implantation, PD12A may be positioned externally to heart 16A and may be connected viaone or more leads or in a leadless fashion to the left ventricle ofheart 16A. In other examples, PD 12A or other PDs may be implantedwithin or externally to other chambers of heart 16A

PD 12A may be constructed to have dimensions to fit within the availablevolume of the left ventricle of heart 16A and to be attachable to awall, e.g., at or near the apex, of the left ventricle of heart 16A. Asmaller size of PD 12A may also reduce the risk of thrombus forming inheart 16A. In some examples, PD 12A may leverage cardiac electrogram(EGM) sensing capabilities of ICD 10A, and therefore, may not includeEGM sensing circuitry. As such, PD 12A may utilize a smaller capacitybattery than in scenarios where regular EGM sensing for electricalcardiac events is performed.

For example, ICD 10A may be configured to sense electrical activity ofheart 16A, such as atrial depolarizations or P-waves, and determine whenPD 12A should deliver one or more pacing signals (e.g., pulses) to theleft ventricle of heart 16A. ICD 10A may then transmit control signalsto PD 12A to provide timing information associated with the pacingpulses that are to be delivered. The timing information may bedetermined based on one or more stored A-V or V-V intervals, which maybe determined by processing circuitry, e.g., of ICD 10A and/or PD 12A,as described above. Upon receiving the control signals from ICD 10A, PD12A may deliver the pacing signals or pulses according to the timinginformation indicated by the received control signals. ICD 10A and PD12A may operate using transmission schedules and communication schedulesto limit the amount of time that PD 12A operates communication circuitrythat receives the control signals in a powered-on state.

In some examples, ICD 10A may also provide pacing signals as part ofcardiac therapy using sensing electrodes 22A and/or 22B ofdefibrillation lead 18A. In other examples, ICD 10A may be coupled toone or more intracardiac leads carrying respective electrodes configuredto be disposed within the right atrium and the right ventricle of heart16A and deliver pacing pulses via these intracardiac leads as part ofthe cardiac therapy along with PD 12A. In other examples, additional PDslike PD 12A may be disposed within the right atrium and/or the rightventricle of heart 16A. Any PD(s) placed within the right atrium and/orright ventricle of heart 16A may be similarly controlled by ICM 10A.Alternatively, one or both PDs in the right atrium and/or rightventricle may provide control signals to PD 12A disposed in the leftventricle of heart 16A.

In another example, PD 12A implanted in the left ventricle and/or a PDimplanted in the right ventricle or other heart chamber may beconfigured for cardiac sensing, delivering other pacing therapy, such asbradycardia pacing therapy, anti-tachycardia pacing (ATP), and/orpost-shock pacing, to heart 16A, and/ or detecting impingement betweenitself or other IMD and heart 16A or another structure. For example, PD12A or a PD implanted in or on the right ventricle may deliver A-Vsynchronous bradycardia pacing therapy, timed relative to the atrialdepolarization based on control signals received from ICD 10A inaccordance with the techniques described herein.

Again, in some examples, PD 12A does not include EGM sensing circuitry.In other examples, PD 12A may be capable of sensing electrical signalsusing the electrodes carried on the housing of PD 12A. These electricalsignals may be electrical signals generated by cardiac muscle andindicative of depolarizations (e.g., a ventricular depolarization orR-wave, or an atrial depolarization or P-wave) and repolarizations(e.g., a ventricular repolarization or T-wave) of heart 16A at varioustimes during the cardiac cycle. PD 12A may analyze the sensed electricalsignals to detect tachyarrhythmia, such as ventricular tachycardia orventricular fibrillation, bradyarrhythmia, or even shocks. In responseto detecting these conditions, PD 12A may, e.g., depending on the typeof arrhythmia or shock, begin to deliver bradycardia pacing therapy,ATP, or post-shock pacing, with or without information from anotherdevice. In some examples, PD 12A may only detect arrhythmias in responseto failing to detect control signals from ICM 10A for a predeterminedperiod, or over a predetermined number of communication windows.

Although FIGS. 1A-1C are illustrated and described in the context of asubsternal ICD system 4A and a PD 12A, techniques in accordance with oneor more aspects of the present disclosure may be applicable to othermedical device systems. One example of another medical device system 8that may implement the techniques of this disclosure is shown in FIG. 2and discussed in further detail below with respect to FIG. 2. In anotherexample, instead of an extravascular ICD (EV-ICD) system, a subcutaneousor submuscular pacing device coupled to a ventricular intracardiac leadmay be implanted within the patient. In this manner, the pacing devicemay provide pacing pulses to the right ventricle of heart 16A via theintracardiac lead, and control PD 12A to provide pacing pulses to theleft ventricle of heart 16A. In another example, a subcutaneous orsubmuscular pacing device coupled to a ventricular intracardiac leadcarrying electrodes may be coupled to a motion sensor, e.g. by the lead,another lead, or wirelessly, and may implement the techniques of thisdisclosure for evaluating contractions to determine if impingement isoccurring during cardiac therapy. As such, in some examples, the sensormay be included as a part of an endocardial lead, such as aleft-endocardial lead. The examples of FIGS. 1A-1C and 2 are forillustrative purposes and should not be considered limiting of thetechniques described herein, in any way.

External device 24 may be configured to communicate with ICD 10A and/orPD 12A. In examples where external device 24 only communicates with oneof ICD 10A or PD 12A, the non-communicative device may receiveinstructions from or transmit data to the device in communication withexternal device 24. In some examples, external device 24 may include,be, or be part of one or more of a handheld computing device, a computerworkstation, or a networked computing device. External device 24 mayinclude a user interface that is configured or otherwise operable toreceive input from a user. In other examples, external device 24 mayprocess user interactions that are relayed remotely, such as via anetworked computing device. External device 24 may process userinteractions to enable users to communicate with PD 12A and/or ICD 10A.For example, external device 24 may process user inputs to send aninterrogation request and retrieve therapy delivery data, to updatetherapy parameters that define therapy, to manage communication betweenPD 12A and/or ICD 10A, or to perform any other activities with respectto PD 12A and/or ICD 10A. Although the user is typically a physician,technician, surgeon, electrophysiologist, clinician, or other healthcareprofessional, the user may be patient 14 in some examples.

External device 24 may also allow the user to define how PD 12A and/orICD 10A senses electrical signals (e.g., EGMs), detects arrhythmias(e.g., tachyarrhythmias), delivers therapy (e.g., CRT), and communicateswith other devices of cardiac medical device system 8A. External device24 may also allow the user to define how PD 12A and system 8A detectimpingements of PD 12A by cardiac tissue. For example, external device24 may be used to change tachyarrhythmia or impingement detectionparameters, such as thresholds or other detection criteria.

The impingement detection parameters may be used by processing circuitryof system 8A, e.g., of ICD 10A, PD 12A, and/or external device 24, toidentify impingements based on one or more characteristics of the signalduring a cardiac cycle satisfying one or more criteria. Thecharacteristics satisfying the criteria may include, for example, afrequency exceeding a threshold and/or a magnitude of motion orthogonalto a primary axis of systolic motion exceeding a threshold, as will bedescribed in greater detail herein. External device 24 may also allow auser to program A-V and/or V-V intervals for cardiac therapy. Forexample, external device 24A may allow a user to select an A-V interval,and program ICD 10A to trigger PD 12A to deliver ventricular pacingpulse at certain time after a detected P-wave based on the selected A-Vinterval, or program PD 12A to deliver ventricular pacing pulse at acertain time after a trigger signal from ICD 10A based on the selectedA-V interval.

External device 24 may take the form of an external programming devicefor one or both of ICD 10A and PD 12A. In some examples, external device24 may additionally or alternatively include processing circuitry forperforming, in whole or part, the impingement detection techniques ofthis disclosure, and/or include a user interface capable of indicatingimpingements or a degree of impingement to a user. In some examples,external device 24 may be present during implantation of PD 12A, e.g.,in an operating or procedure room, and provide an indication ofimpingement, e.g., to an implanting physician, during implantation of PD12A.

External device 24 may communicate with PD 12A and/or ICD system 4A viawireless communication using any techniques known in the art. Examplesof communication techniques may include, for example, proprietary andnon-proprietary radiofrequency (RF) telemetry, inductive telemetry,acoustics, and tissue conduction communication (TCC), but othertechniques are also contemplated. During TCC, current is driven throughthe tissue between two or more electrodes of a transmitting device. Theelectrical signal spreads and may be detected at a distance by measuringthe voltage generated between two electrodes of a receiving device.

In some examples, PD 12A and ICD 10A may engage in communication tofacilitate the appropriate detection of impingement, detection ofarrhythmias, and/or appropriate delivery of pacing therapy. Thecommunication may include one-way communication in which one device isconfigured to transmit communication messages and the other device isconfigured to receive those messages according to the respectiveschedule. The communication may instead include two-way communication inwhich each device is configured to transmit and receive communicationmessages. Both of PD 12A and ICD 10A may be configured to toggle betweenone-way communication modes and two-way communication modes. Thecommunication may be via TCC or other communication signals, e.g., RFcommunication signals.

FIG. 2 is a conceptual diagram illustrating an example front view ofpatient 14 implanted with another example medical device system 8B thatincludes an insertable cardiac monitoring (ICM) device 10B that isinserted subcutaneously or substernally in the patient, and PD 12Bimplanted either epicardially or within a cardiac chamber of patient 14,in accordance with one or more aspects of this disclosure. Componentsillustrated in FIG. 2 with like numbers of those of FIGS. 1A-1C may besimilarly configured and may provide similar functionality to thesimilarly-numbered components illustrated in FIGS. 1A-1C. Medical devicesystem 8B of FIG. 2 may leverage cardiac signal sensing capabilities ofICM 10B or PD 12B for collecting, measuring, and storing various formsof diagnostic data, including generating any corresponding reports oralerts. In certain cases, ICM 10B or PD 12B may directly analyzecollected diagnostic data and generate any corresponding reports oralerts. In some cases, however, ICM 10B or PD 12B may send diagnosticdata to external device 24. In some examples, ICM 10B may take the formof a Reveal LINQ™ ICM, available from Medtronic plc, of Dublin, Ireland.

Medical device system 8A of FIGS. 1A-1C and medical device system 8B ofFIG. 2 may each be configured to detect and indicate impingementaccording to the techniques of this disclosure. As such, the impingementdetection and reporting techniques of this disclosure are describedhereinafter as being performed generically by “medical device system 8,”and/or “PD 12,” although it will be appreciated that the describedtechniques may be performed by the respective correspondingsystems/devices illustrated in FIGS. 1A-1C or FIG. 2.

Medical device system 8 and/or components thereof may be configured todetect activity of heart 16, and deliver pacing therapy in a timedrelationship to such activity based on a stored interval, e.g., an A-Vor V-V interval. As described above, IMDs 10 may, in various examples,represent different types of cardiac monitoring (and in some casestherapy) devices that may be implanted substernally, subcutaneously, orelsewhere in the body of patient 14. In any of these implementations,IMD 10 includes interface hardware and sensing circuitry that senses acardiac signal that varies as a function of a cardiac cycle of heart 16.For instance, the sensing circuitry of IMD 10 may detect an atrialand/or ventricular activation event based on the features of the signalduring the cardiac cycle. IMD 10 may provide an indication to PD 12,such that PD 12 delivers ventricular pacing at the A-V or V-V intervalafter the event, in response to IMD detecting the activation event.

According to the techniques of this disclosure, a motion sensor withinor coupled to PD 12, e.g., a three-dimensional accelerometer, maygenerate a signal that indicates motion of PD 12, including impingementof PD 12 with the heart or other structures. According to the techniquesof this disclosure, processing circuitry, e.g., of PD 12, IMD 10,external device 24, and/or any device described herein, may identifyimpingements based on features of the motion signal during the cardiaccycle, e.g., that are not associated with non-impinged motion of PD 12within the heart during the cardiac cycle. Reducing impingement betweenmedical device systems 8A and 8B in general, and PD 12 in particular,and other structures may be desired.

The processing circuitry may also generate diagnostic information basedon detected impingement, e.g., whether impingement is detected or thenumbers of beats exhibiting impingement, which may be reported to auser. The diagnostic information may include values of one or moremetrics indicating an amount of impingement, e.g., a percentage of beatswhere PD 12 has acceptable or unacceptable levels of impingement.Indicating impingement to a user may include a binary indication ofwhether or not impingement has occurred at a current implant location,or an amount of impingement, such as the aforementioned numbers orpercentages, or impingement levels, e.g., high, medium, or low, whichmay be indicated by color, text, other graphics, or sound, anddetermined based on the aforementioned numbers or percentages. Theindication of impingement may be provided via a user interface, such asexternal device 14 or another computing device. An implanting clinicianmay explant and/or change an implant location of PD 12 based on theindication of impingement.

FIG. 3 is a conceptual drawing illustrating an example configuration ofICM 10B illustrated in FIG. 2. In the example shown in FIG. 3, ICM 10Bmay be embodied as a monitoring device having housing 32, proximalelectrode 34 and distal electrode 36. Housing 32 may further includefirst major surface 38, second major surface 40, proximal end 42, anddistal end 44. Housing 32 encloses electronic circuitry located insidethe ICM 10B and protects the circuitry contained therein from bodyfluids. Electrical feedthroughs provide electrical connection ofelectrodes 34 and 36.

In the example shown in FIG. 3, ICM 10B is defined by a length L, awidth W and thickness or depth D and is in the form of an elongatedrectangular prism wherein the length L is much larger than the width W,which in turn is larger than the depth D. In one example, the geometryof the ICM 10B—a width W greater than the depth D—is selected to allowICM 10B to be inserted under the skin of the patient using a minimallyinvasive procedure and to remain in the desired orientation duringinsertion. For example, the device shown in FIG. 3 includes radialasymmetries (notably, the rectangular shape) along the longitudinal axisthat maintains the device in the proper orientation following insertion.For example, in one example the spacing between proximal electrode 34and distal electrode 36 may range from thirty millimeters (mm) tofifty-five mm, thirty-five mm to fifty-five mm, and from forty mm tofifty-five mm and may be any range or individual spacing fromtwenty-five mm to sixty mm.

In addition, ICM 10B may have a length L that ranges from thirty mm toabout seventy mm. In other examples, the length L may range from fortymm to sixty mm, forty-five mm to sixty mm and may be any length or rangeof lengths between about thirty mm and about seventy mm. In addition,the width W of major surface 38 may range from three mm to ten mm andmay be any single or range of widths between three mm and ten mm. Thethickness of depth D of ICM 10B may range from two mm to nine mm. Inother examples, the depth D of ICM 10B may range from two mm to five mmand may be any single or range of depths from two mm to nine mm.

Furthermore, ICM 10B, according to an example of the present disclosure,has a geometry and size designed for ease of implant and patientcomfort. Examples of ICM 10B described in this disclosure may have avolume of three cubic centimeters (cm) or less, one-and-a-half cubic cmor less or any volume between three and one-and-a-half cubiccentimeters. In addition, in the example shown in FIG. 3, proximal end42 and distal end 44 are rounded to reduce discomfort and irritation tosurrounding tissue once inserted under the skin of the patient. In someexamples, ICM 10B, including instrument and method for inserting ICM10B, is configured as described, for example, in U.S. Patent PublicationNo. 2014/0276928, which is entitled, “SUBCUTANEOUS DELIVERY TOOL,” andpublished on Sep. 18, 2014. U.S. Patent Publication No. 2014/0276928 toVanderpool et al. is incorporated herein by reference in its entirety.In some examples, ICM 10B is configured as described, for example, inU.S. Patent Publication No. 2016/0310031, which is entitled, “METHOD ANDAPPARATUS FOR DETERMINING A PREMATURE VENTRICULAR CONTRACTION IN AMEDICAL MONITORING DEVICE,” and published on Oct. 27, 2016. U.S. PatentPublication No. 2016/0310031 to Sarkar is incorporated herein byreference in its entirety.

In the example shown in FIG. 3, once inserted within the patient, thefirst major surface 38 faces outward toward the skin of the patientwhile the second major surface 40 is located opposite the first majorsurface 38. Consequently, the first and second major surfaces may facein directions along a sagittal axis of patient 14A (e.g., see FIG. 2),and this orientation may be consistently achieved upon implantation dueto the dimensions of ICM 10B. Additionally, an accelerometer, or axis ofan accelerometer, may be oriented along the sagittal axis.

Proximal electrode 34 and distal electrode 36 are used to sense cardiacsignals, e.g., cardiac EGM signals, intra-thoracically orextra-thoracically, which may be sub-muscularly or subcutaneously. EGMsignals may be stored in a memory of the ICM 10B, and EGM data may betransmitted via integrated antenna 52 to another medical device, whichmay be another implantable device or an external device, such asexternal device 14A. In some example, electrodes 34 and 36 mayadditionally or alternatively be used for sensing any bio-potentialsignal of interest, which may be, for example, any EGM,electroencephalogram (EEG), electromyogram (EMG), or a nerve signal,from any implanted location.

In the example shown in FIG. 3, proximal electrode 34 is close to theproximal end 42, and distal electrode 36 is close to distal end 44. Inthis example, distal electrode 36 is not limited to a flattened, outwardfacing surface. Distal electrode 36 may extend from first major surface38 around rounded edges 46 and/or end surface 48 and onto the secondmajor surface 40 so that the electrode 36 has a three-dimensional curvedconfiguration. In the example shown in FIG. 3, proximal electrode 34 islocated on first major surface 38 and is substantially flat, outwardfacing. However, in other examples, proximal electrode 34 may utilizethe three-dimensional curved configuration illustrated with respect todistal electrode 36 in FIG. 3, providing a three-dimensional proximalelectrode. In other examples still, distal electrode 36 may utilize asubstantially flat, outward facing electrode located on first majorsurface 38 like that shown in FIG. 3 with respect to proximal electrode34.

The various electrode configurations allow for configurations in whichproximal electrode 34 and distal electrode 36 are located on both firstmajor surface 38 and second major surface 40. In other configurations,such as the configuration shown in FIG. 3, only one of proximalelectrode 34 or distal electrode 36 is located on both major surfaces 38and 40. In still other configurations, both proximal electrode 34 anddistal electrode 36 are located on one of the first major surface 38 orthe second major surface 40 (i.e., proximal electrode 34 may be locatedon first major surface 38 while distal electrode 36 may be located onsecond major surface 40). In another example, ICM 10B may includeelectrodes on both major surface 38 and 40 at or near the proximal anddistal ends of the device, such that a total of four electrodes areincluded on ICM 10B. Electrodes 34 and 36 may be formed of a pluralityof different types of biocompatible conductive material, e.g., stainlesssteel, titanium, platinum, iridium, or alloys thereof, and may utilizeone or more coatings such as titanium nitride or fractal titaniumnitride.

In the example shown in FIG. 3, proximal end 42 includes a headerassembly 50 that includes one or more of proximal electrode 34,integrated antenna 52, anti-migration projections 54, and/or suture hole56. Integrated antenna 52 is located on the same major surface (i.e.,first major surface 38) as proximal electrode 34 and is also included aspart of header assembly 50. Integrated antenna 52 allows ICM 10B totransmit and/or receive data. In other examples, integrated antenna 52may be formed on the opposite major surface as proximal electrode 34, ormay be incorporated within the housing 32 of ICM 10B. In the exampleshown in FIG. 3, anti-migration projections 54 are located adjacent tointegrated antenna 52 and protrude away from first major surface 38 toprevent longitudinal movement of the device. In the example shown inFIG. 3 anti-migration projections 54 includes a plurality (e.g., nine)small bumps or protrusions extending away from first major surface 38.

As discussed above, in other examples, anti-migration projections 54 maybe located on the opposite major surface as proximal electrode 34 and/orintegrated antenna 52. In addition, in the example shown in FIG. 3header assembly 50 includes suture hole 56, which provides another meansof securing ICM 10B to the patient to prevent movement following insert.In the example shown, suture hole 56 is located adjacent to proximalelectrode 34. In one example, header assembly 50 is a molded headerassembly made from a polymeric or plastic material, which may beintegrated or separable from the main portion of ICM 10B.

FIG. 4 is a conceptual drawing illustrating an example PD 12, which maycorrespond to either or both of PD 12A of FIG. 1A or PD 12B of FIG. 2.In addition, PD 12 may correspond to IMD 240 in FIGS. 11A-H. As shown inFIG. 4, PD 12 includes case 50, cap 58, electrode 60, electrode 52,fixation mechanisms 62, flange 54, and opening 56. Together, case 50 andcap 58 may be considered the housing of PD 12. In this manner, case 50and cap 58 may enclose and protect the various electrical componentswithin PD 12. Case 50 may enclose substantially all the electricalcomponents, and cap 58 may seal case 50 and create the hermeticallysealed housing of PD 12. Although PD 12 is generally described asincluding one or more electrodes, PD 12 may typically include at leasttwo electrodes (e.g., electrodes 52 and 60) to deliver an electricalsignal (e.g., therapy such as CRT) and/or provide at least one sensingvector. Electrodes 52 and 60 are carried on the housing created by case50 and cap 58. In this manner, electrodes 52 and 60 may be consideredleadless electrodes.

In the example of FIG. 4, electrode 60 is disposed on the exteriorsurface of cap 58. Electrode 60 may be a circular electrode positionedto contact cardiac tissue upon implantation. Electrode 52 may be a ringor cylindrical electrode disposed on the exterior surface of case 50.Both case 50 and cap 58 may be electrically insulating. Electrode 60 maybe used as a cathode, and electrode 52 may be used as an anode, or viceversa, for delivering appropriate cardiac therapy (CRT, bradycardiapacing, ATP, post-shock pacing, etc.). However, electrodes 52 and 60 maybe used in any stimulation configuration. In addition, electrodes 52 and60 may be used to detect intrinsic electrical signals from cardiacmuscle. In other examples, PD 12 may include three or more electrodes,where each electrode may deliver therapy and/or detect intrinsicsignals. CRT and other pacing delivered by PD 12 may be “painless” topatient 14 or even undetectable by patient 14 since the electricalstimulation occurs very close to or at cardiac muscle and at relativelylow energy levels compared with alternative devices.

Fixation mechanisms 62 may attach PD 12 to cardiac tissue. Fixationmechanisms 62 may be active fixation tines, screws, clamps, adhesivemembers, or any other types of attaching a device to tissue. As shown inthe example of FIG. 4, fixation mechanisms 62 may be constructed of amemory material that retains a preformed shape. During implantation,fixation mechanisms 62 may be flexed forward to pierce tissue andallowed to flex back towards case 50. In this manner, fixationmechanisms 62 may be embedded within the target tissue.

Flange 54 may be provided on one end of case 50 to enable tethering orextraction of PD 12. For example, a suture or other device may beinserted around flange 54 and/or through opening 56 and attached totissue. In this manner, flange 54 may provide a secondary attachmentstructure to tether or retain PD 12 within heart 16 if fixationmechanisms 62 fail. Flange 54 and/or opening 56 may also be used toextract PD 12 once the PD needs to be explanted (or removed) frompatient 14 if such action is deemed necessary.

In another example, PD 12 may be configured to be implanted external toheart 16, e.g., near or attached to the epicardium of heart 16. Anelectrode carried by the housing of PD 12 may be placed in contact withthe epicardium and/or one or more electrodes placed in contact with theepicardium at locations sufficient to provide an indication ofimpingement. In any example, IMD 10 may communicate with one or moreleadless or leaded devices implanted internal or external to heart 16.

FIG. 5 is a block diagram of an example configuration of an IMD 10 thatis configured according to one or more aspects of this disclosure. IMD10 of FIG. 5 may, in various use case scenarios, represent an example ofICD 10A of FIGS. 1A-1C or ICM 10B of FIG. 2. IMD 10 includes two or moreelectrodes 71A-N (collectively “electrodes 71”), which may correspond todefibrillation electrodes 20 (FIGS. 1A-C), sensing electrodes 22 FIGS.1A-C), one or more housing electrodes of ICD 10A (FIGS. 1A-C), orelectrodes 34 and 36 (FIG. 3).

IMD 10 may include processing circuitry 70 for controlling sensingcircuitry 76, communication circuitry 78, (optionally) switchingcircuitry 72, memory 82, and (optionally) therapy generation circuitry80. The optional nature of switching circuitry 72 and therapy generationcircuitry 80 is shown using dashed-line borders to indicate the optionalaspect, in FIG. 5. As one example, therapy generation circuitry 80 isindicated as optional because some embodiments of an IMD configured asan ICM do not deliver therapy. Switching circuitry 72 may include one ormore switches, such as metal-oxide-semiconductor field-effecttransistors (MOSFETs) or bipolar transistors. Processing circuitry 70may control switching circuitry 72 to connect selected groupings ofelectrodes 71 to sensing circuitry 76 to sense one or more physiologicalelectrical signals.

Sensing circuitry 76 is configured to receive cardiac electrical signalsfrom selected combinations of two or more electrodes 71 and sensecardiac events attendant to depolarization and repolarization of cardiactissue. Sensing circuitry 76 may include one or more sensing channels,each of which may be selectively coupled to respective combinations ofelectrodes 71 to detect electrical activity of a particular chamber ofheart 16, e.g., one or more atrial and/or ventricular sensing channels.Each sensing channel may be configured to amplify, filter and rectifythe cardiac electrical signal received from selected electrodes coupledto the respective sensing channel to detect cardiac events, e.g., P-waveand R-waves. For example, each sensing channel may include one or morefilters and amplifiers for filtering and amplifying a signal receivedfrom a selected pair of electrodes. The resulting cardiac electricalsignal may be passed to cardiac event detection circuitry that detects acardiac event when the cardiac electrical signal crosses a sensingthreshold. The cardiac event detection circuitry may include arectifier, filter and/or amplifier, a sense amplifier, comparator,and/or analog-to-digital converter. Sensing circuitry 76 may output anindication to processing circuitry 70 in response to sensing a cardiacevent in a chamber of interest, e.g., a P-wave or R-wave. In thismanner, processing circuitry 70 may receive detected cardiac eventsignals corresponding to the occurrence of detected P-waves and R-waves.Indications of detected R-waves may be used by processing circuitry 70for detecting ventricular arrhythmia episodes, and indications ofdetected P-waves may be used by processing circuitry 70 for detectingatrial arrhythmia episodes. Sensing circuitry 76 may also pass one ormore digitized EGM signals to processing circuitry 70 for analysis,e.g., for use in cardiac rhythm discrimination and for morphologicalanalysis.

Communication circuitry 78 may include circuitry for generating andmodulating, and in some cases receiving and demodulating, continuousand/or pulsatile communication waveforms. Communication circuitry 78 maybe configured to transmit and/or receive one or both of RF signals viaan antenna (not shown) or TCC signals via electrodes 71. Although notshown in FIG. 5, communication circuitry 78 may be coupled to a selectedtwo or more electrodes 71 via switching circuitry 72 for TCC.

In some examples, processing circuitry 70 may control switchingcircuitry 72 to connect electrodes 71 to therapy generation circuitry 80to deliver a therapy pulse, such as a pacing, cardioversion, ordefibrillation pulse to the heart. Therapy generation circuitry 80 iselectrically coupleable to electrodes 71 and is configured to generateand deliver electrical therapy to heart 16 via selected combinations ofelectrodes 71. Therapy generation circuitry 80 may include chargingcircuitry, and one or more charge storage devices, such as one or morehigh voltage capacitors and/or one or more low voltage capacitors.Switching circuitry 72 may control when the capacitor(s) are dischargedto selected combinations of electrodes 71. Therapy generation circuitry80 and/or processing circuitry 70 may control the frequency, amplitude,and other characteristics of the therapy pulses. Therapy generationcircuitry 80 may deliver the therapy pulses to electrodes 71 whenswitching circuitry 72 connects therapy generation circuitry 80 toelectrodes 71.

Processing circuitry 70 may control switching circuitry 72 by sendingcontrol signals to the control terminals of one or more switches ofswitching circuitry 72. The control signals may control whether theswitches of switching circuitry 72 conduct electricity between the loadterminals of the switches. If switching circuitry 72 includes MOSFETswitches, the control terminals may include gate terminals, and the loadterminals may include drain terminals and source terminals.

Processing circuitry 70 may include various types of hardware, includingone or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalentintegrated or discrete logic circuitry, as well as any combinations ofsuch components. The term “processing circuitry” may generally refer toany of the foregoing logic circuitry, alone or in combination with otherlogic circuitry, or any other equivalent circuitry. Processing circuitry70 represents hardware that may be configured to implement firmwareand/or software that sets forth one or more of the algorithms describedherein. Memory 82 includes computer-readable instructions that, whenexecuted by processing circuitry 70, cause IMD 10 and processingcircuitry 70 to perform various functions attributed to IMD 10 andprocessing circuitry 70 herein. Memory 82 may include any volatile,non-volatile, magnetic, optical, or electrical media, such as arandom-access memory (RAM), read-only memory (ROM), non-volatile RAM(NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory,or any other digital media.

In some examples, processing circuitry 70 receives indications of theoccurrence of P-waves or other atrial events (or R-wave or otherventricular events) from sensing circuitry 76, or identifies theoccurrence of P-waves or other atrial events by processing of afar-field EGM signal received from sensing circuitry using any of avariety of techniques known in the art. In response to the atrial orventricular event, processing circuitry 70 may control communicationcircuitry 78 to transmit a signal to intracardiac PD 12. The signalcauses intracardiac PD 12 to deliver a ventricular pacing pulse forcardiac therapy, absent an intrinsic ventricular depolarization prior toexpiration of a timing interval, such as an A-V or V-V interval. Asdescribed above, one or both of IMD 10 and intracardiac PD 12 may storeadjustable timing intervals that control the delivery of CRT based on anA-V interval or V-V interval. IMD 10 may store such intervals in memory82.

In some examples, processing circuitry 70 of IMD 10 may receive a motionsignal from a sensor of intracardiac PD 12. The motion sensor ofintracardiac PD 12 may be configured to produce a signal that indicatesmotion of PD 12, e.g., motion of the housing of PD 12, includingimpingements of PD 12. Processing circuitry 70 may, according to thetechniques described herein, detect impingements of PD 12 based onfeatures of the signal from the sensor that indicates motion of PD 12.Processing circuitry 70 may identify one or more features of the signalduring the cardiac contraction, determine whether the motion during thecardiac contraction indicates impingement based on the one or morefeatures.

Processing circuitry 70 may additionally or alternatively receive amotion signal from the sensor of PD 12 that indicates mechanicalactivity of heart. Processing circuitry 70 may determine whether acontraction is fusion or not based on features of the cardiaccontraction as indicated in the motion signal. Based on this evaluationof the contraction, processing circuitry 70 may control a timinginterval stored in memory 82 and, for example, used by the processingcircuitry to determine when to transmit a signal to PD 12 or when toinstruct PD 12 to deliver a ventricular pacing pulse. Processingcircuitry 70 may transmit a signal to intracardiac PD 12 viacommunication circuitry 78 to adjust a timing interval used byintracardiac PD 12. Techniques for adjusting therapy intervals based onevaluation of cardiac contraction are described, for example, in U.S.Provisional Patent Application Ser. No. 62/615,689 (Attorney Docket No.C00014601.USP1) filed Jan. 10, 2018 and entitled “ADAPTIVE CARDIACRESYNCHRONIZATION THERAPY,” and U.S. Provisional Patent Application Ser.No. 62/615,703 (Attorney Docket No. C00014600.USP1) filed Jan. 10, 2018and entitled “CARDIAC RESYNCHRONIZATION THERAPY DIAGNOSTICS,” both ofwhich are herein incorporated by reference in their entirety.

FIG. 6 is a functional block diagram illustrating an exampleconfiguration of PD 12, which may correspond to PD 12A of FIGS. 1A-1C,PD 12B of FIG. 2, PD 12 of FIG. 4, and IMD 240 of FIGS. 9A-9H. In theillustrated example, PD 12 includes processing circuitry 90, memory 92,therapy generation circuitry 96, sensing circuitry 98, motion sensor100, and communication circuitry 94. Memory 92 includescomputer-readable instructions that, when executed by processingcircuitry 90, cause PD 12 and processing circuitry 90 to perform variousfunctions attributed to PD 12 and processing circuitry 90 herein (e.g.,analyzing a motion signal from sensor 100 that indicates motion of theintracardiac PD and sensor 100 within the heart during contraction, andidentifying impingements based on characteristics of the signal during acardiac cycle, such as a frequency exceeding a threshold and/or amagnitude of motion orthogonal to a primary axis of systolic motionexceeding a threshold). Memory 92 may include any volatile,non-volatile, magnetic, optical, or electrical media, such as arandom-access memory (RAM), read only memory (ROM), non-volatile RAM(NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory,or any other digital or analog media.

Processing circuitry 90 may include any one or more of a microprocessor,a controller, a digital signal processor (DSP), an application specificintegrated circuit (ASIC), a field-programmable gate array (FPGA), orequivalent discrete or analog logic circuitry. In some examples,processor 90 may include multiple components, such as any combination ofone or more microprocessors, one or more controllers, one or more DSPs,one or more ASICs, or one or more FPGAs, as well as other discrete orintegrated logic circuitry. The functions attributed to processingcircuitry 90 herein may be embodied as software, firmware, hardware orany combination thereof.

Processing circuitry 90 controls therapy generation circuitry 96 todeliver stimulation therapy to heart 16 according to therapy parameters,which may be stored in memory 92. For example, processing circuitry 90may control therapy generation circuitry 96 to deliver electrical pulseswith the amplitudes, pulse widths, frequency, or electrode polaritiesspecified by the therapy parameters. In this manner, therapy generationcircuitry 96 may deliver pacing pulses to heart 16 via electrodes 52 and60. Although PD 12 may only include two electrodes, e.g., electrodes 52and 60, PD 12 may utilize three or more electrodes in other examples. PD12 may use any combination of electrodes to deliver therapy and/ordetect electrical signals from patient 14.

Therapy generation circuitry 96 is electrically coupled to electrodes 52and 60 carried on the housing of PD 12. In the illustrated example,therapy generation circuitry 96 is configured to generate and deliverelectrical stimulation therapy to heart 16. For example, therapygeneration circuitry 96 may deliver pulses to a portion of cardiacmuscle within heart 16 via electrodes 52 and 60. In some examples,therapy generation circuitry 96 may deliver pacing stimulation in theform of electrical pulses. In other examples, signal generator maydeliver one or more of these types of stimulation in the form of othersignals, such as sine waves, square waves, or other substantiallycontinuous time signals. Therapy generation circuitry 96 may includecharging circuitry, and one or more charge storage devices, such as oneor more capacitors. Switching circuitry (not shown) may control when thecapacitor(s) are discharged to electrodes 52 and 60.

Sensing circuitry 98 monitors signals from at least one of electrodes 52and 60 to monitor electrical activity of heart 16, impedance, or anotherelectrical phenomenon. Sensing may be done to determine heart rates orheart rate variability, or to detect ventricular dyssynchrony,arrhythmias (e.g., tachyarrhythmias) or other electrical signals.Sensing circuitry 98 may include switching circuitry to select theelectrode polarity used to sense the heart activity. In examples withmore than two electrodes, processing circuitry 90 may select theelectrodes that function as sense electrodes, i.e., select the sensingconfiguration, via the switching circuitry within sensing circuitry 98.Sensing circuitry 98 may include one or more detection channels, each ofwhich may be coupled to a selected electrode configuration for detectionof cardiac signals via that electrode configuration. Some detectionchannels may be configured to detect cardiac events, such as R-waves,and provide indications of the occurrences of such events to processingcircuitry 90, e.g., as described in U.S. Pat. No. 5,117,824 to Keimel etal., which issued on Jun. 2, 1992 and is entitled, “APPARATUS FORMONITORING ELECTRICAL PHYSIOLOGIC SIGNALS,” and is incorporated hereinby reference in its entirety. Processing circuitry 90 may control thefunctionality of sensing circuitry 98 by providing signals via adata/address bus.

In addition to detecting and identifying specific types of cardiacrhythms), sensing circuitry 98 may also sample the detected intrinsicsignals to generate an electrogram or other time-based indication ofcardiac events. Processing circuitry 90 may also be able to coordinatethe delivery of pacing pulses from different PDs, e.g., implanted indifferent chambers of heart 16, such as an PD implanted in the otherventricle. For example, processing circuitry 90 may identify deliveredpulses from other PDs via sensing circuitry 98 and updating pulsetiming. In other examples, PDs may communicate with each other viacommunication circuitry 94 and/or instructions over a carrier wave (suchas a stimulation waveform).

Memory 92 may be configured to store a variety of operationalparameters, therapy parameters, sensed and detected data, and any otherinformation related to the therapy and treatment of patient 14. In theexample of FIG. 6, memory 92 may store sensed EGMs, signals receivedfrom motion sensor 100 with features that may indicate impingement,communications from IMD 10, therapy parameter values, such as timingintervals that control the timing of cardiac therapy pacing pulses orother cardiac therapy control parameter values and values of one or moremetrics that indicate cardiac therapy effectiveness. In some examples,memory 92 may act as a temporary buffer for storing data until it can beuploaded to IMD 10, another implanted device, or external device 24.

Motion sensor 100 may be contained within the housing of PD 12 andinclude one or more accelerometers, gyroscopes, electrical or magneticfield sensors, or other devices capable of detecting motion and/orposition of PD 12. For example, motion sensor 100 may include athree-dimensional accelerometer that is configured to detectaccelerations in any direction in space. Motion sensor 100 providesfeedback about motion of PD 12, e.g., of the housing of PD 12. Themotion indicated by sensor 100 may include motion of PD 12 due to themechanical contraction pattern of the heart, including radialdisplacement and impingement of PD 12 with tissue. In this manner,motion sensor 100 may be used to detect PD 12 motion that may beindicative of cardiac events and/or noise.

For example, processing circuitry 90 may monitor the accelerations frommotion sensor 100 to detect an impingement, e.g. collision, of PD 12with another structure, such as cardiac tissue, another IMD, a componentof another IMD, or a separated component of PD 12, such as a separatedfixation mechanism. In some examples, during implant, e.g., during theprocess of checking initial pacing impedance and pacing thresholds at animplant location, PD 12 may monitor the motion signal throughout one ormore cardiac cycles to determine if impingement is occurring. Detectionof impingement at an implant location may prompt a clinician to changethe implant location of PD 12. Since PD 12 may move with a chamber wallof heart 16, the detected changes in acceleration may also be indicativeof contractions. Therefore, PD 12 may be configured to, based on thesignal from sensor 100, identify heart rates and confirm ventriculardyssynchrony sensed via sensing circuitry 98.

As described in greater detail below, such as with respect to FIGS. 12Aand 12B, the one or more features of the motion signal that may indicateimpingement of PD 12 with cardiac tissue may comprise one or more of anamount or a direction of motion relative to a point of origin during theheartbeat. An amount of motion may be a distance relative to anotherpoint, such as an origin, or a velocity of the motion, e.g., an averageor maximum velocity, in some examples. In some examples, the amount ofmotion is in at least one direction other than the primary axis ofmotion during the heartbeat, e.g., an amount of motion in at least oneplane orthogonal to the primary axis of motion during the heartbeat.

During left-ventricular contraction of a relatively healthy heart, allleft-ventricular walls shorten synchronously and with similar force.Such a contraction pulls the atrio-ventricular plane and theleft-ventricular apex toward each other. The movement of theatrio-ventricular plane and the left-ventricular apex toward each otherdefines the primary axis of motion during the heartbeat. Further, in thecase of a totally synchronous activation of all left-ventricular walls,there is a total force balance at the apex, and there is minimal or noresulting radial motion component at the apex that is associated withcardiac contraction.

In examples in which one or more sensor(s) 100 are other than anaccelerometer, the features used to evaluate the motion signal using thetechniques described herein may be the same or different than thoseprovided by an accelerometer. For example, a gyroscope may providerotational motion information different from that provided byaccelerometers, but similar techniques may be used to evaluate themotion signal. For example, motion in directions, at frequencies, and/orhaving velocities other than those associated with cardiac contractionmay be present in such signals and indicate impingement.

Motion sensor(s) 100 may be located at or near the apex of the heart,e.g., because PD 12 is implanted at that location. However, motionsensor(s) 100 may be implanted at other locations, e.g., on theventricular free wall or septum. In either case, processing circuitrymay detect motion in a direction other than the primary axis of motionduring the cardiac contraction based on the signal from motion sensor(s)100. Further, motion sensor(s) 100 may detect motion or displacement inany radial direction away from the origin point of the cardiac cycle.The x-axis and y-axis component of the radial displacement may be eitherdetermined individually for each x-axis and y-axis component or thecombined vector length of the x-axis and y-axis component.

Techniques for evaluating the signal from motion sensor 100 to detectimpingement may additionally or alternatively include comparing currentsignals from sensor 100, or values derived from the current signal, totemplate or baseline signals or values. Based on the comparison,processing circuitry may determine differences between the signal andthe template, which may be compared to thresholds to determine whetherthe signal “matches” the template, e.g., is sufficiently similar to thetemplate. The one or more templates may be stored in memory 92 (oranother memory of system 8). The one or more templates may be generatedby processing circuitry 90 or other processing circuitry based on themotion signal during one or more previous beats of known classification(such as by averaging the signal for a plurality of known beats of agiven classification), either of the particular patient, or from apopulation of one or more similar patients. The one or more templatesmay include one or more of a template with acceptable level ofimpingement and a template with an unacceptable level of impingement,and processing circuitry may characterize a given signal as one with ornot with an acceptable level of impingement based on whose template thesignal best matches.

Further, the templates need not take the form of one or moresubstantially continuous-time signals, representing a number of values,from one or more sensors during a heartbeat (or portion of such asignal). Rather, a template may take the form of a template value forany one or more of the signal features disclosed herein, e.g., frequencyor motion orthogonal to the primary axis of contraction. The templatevalue may be, but need not necessarily be, determined based on atemplate signal or otherwise determined from motion signals of knownclassification (such as by averaging the signal for a plurality of knownbeats of a given classification), either of the particular patient, orfrom a population of one or more similar patients. Template values mayinclude, as examples, values of: an amplitude of the signal during theheartbeat, a frequency of the signal during the heartbeat, a duration ofthe signal during the heartbeat, a maximum of the signal during theheartbeat, a minimum of the signal during the heartbeat, a rate ofchange of the signal during the heartbeat, a ratio of the maximum andthe minimum during the heartbeat, a polarity of the signal during theheartbeat, or an amount of motion in one or more particular directions,such as orthogonal to the primary axis of motion during the heartbeat.Again, an amount of motion may be a displacement or velocity, asexamples. The templates may include template values for multiple signalfeatures. Although described in the context of processing circuitry 90of intracardiac PD 12, processing circuitry of any one or more devicesdescribed herein may similarly use templates to identify impingement.

Communication circuitry 94 includes any suitable hardware, firmware,software or any combination thereof for communicating with anotherdevice, such as external device 24 or IMD 10, via TCC or RF signals, asdescribed herein. In some examples, communication circuitry 94 may beconfigured for TCC communication with IMD 10 via electrodes 52 and 60.PD 12 may communicate with external device 24 via IMD 10, orcommunication circuitry 94 may be configured for RF communication withexternal device 24, e.g., via an antenna. In some examples, PD 12 maysignal external device 24 to further communicate with and pass the alertthrough a network such as the Medtronic CareLink® Network developed byMedtronic plc of Dublin, Ireland, or some other network linking patient14 to a clinician. PD 12 may spontaneously transmit information to thenetwork or in response to an interrogation request from a user.

FIG. 7 is a functional block diagram illustrating an exampleconfiguration of external device 24. As shown in FIG. 7, external device24 may include processing circuitry 110, memory 112, user interface 114,and communication circuitry 116. External device 24 may be a dedicatedhardware device with dedicated software for communication with, e.g.,programming of, PD 12 and/or IMD 10. Alternatively, external device 24may be an off-the-shelf computing device running an application thatenables external device 24 to program and/or otherwise communicate withPD 12 and/or IMD 10.

A user may use external device 24 to configure the operationalparameters of and retrieve data from PD 12 and/or IMD 10. In oneexample, external device 24 may communicate directly to both PD 12 andIMD 10. In other examples, external device 24 may communicate to one ofPD 12 and IMD 10, and that device may relay any instructions orinformation to or from the other device. The clinician may interact withexternal device 24 via user interface 114, which may include display topresent graphical user interface to a user, and a keypad or anothermechanism for receiving input from a user. In addition, the user mayreceive an alert or notification from IMD 10 indicating that a shock hasbeen delivered, any other therapy has been delivered, or any problems orissues related to the treatment of patient 14.

Processing circuitry 110 may take the form one or more microprocessors,DSPs, ASICs, FPGAs, programmable logic circuitry, or the like, and thefunctions attributed to processing circuitry 110 herein may be embodiedas hardware, firmware, software or any combination thereof. Memory 112may store instructions that cause processing circuitry 110 to providethe functionality ascribed to external device 24 herein, and informationused by processing circuitry 110 to provide the functionality ascribedto external device 24 herein. Memory 112 may include any fixed orremovable magnetic, optical, or electrical media, such as RAM, ROM,CD-ROM, hard or floppy magnetic disks, EEPROM, or the like. Memory 112may also include a removable memory portion that may be used to providememory updates or increases in memory capacities. A removable memory mayalso allow patient data to be easily transferred to another computingdevice, or to be removed before external device 24 is used to programtherapy for another patient.

External device 24 may communicate wirelessly with PD 12 and/or IMD 10,such as using RF communication or proximal inductive interaction. Thiswireless communication is possible with communication circuitry 116,which may be coupled to an internal antenna or an external antenna. Anexternal antenna that is coupled to external device 24 may correspond tothe programming head that may be placed over heart 16 or the location ofthe intend implant, as described above with reference to FIG. 1.Communication circuitry 116 may be configured with circuitry likecommunication circuitry 78 of FIG. 5.

Communication circuitry 116 may also be configured to communicate withanother computing device via wireless communication techniques, ordirect communication through a wired connection. Examples of localwireless communication techniques that may be employed to facilitatecommunication between external device 24 and another computing deviceinclude RF communication according to the 802.11 or Bluetoothspecification sets, infrared communication, e.g., according to the IrDAstandard, or other standard or proprietary telemetry protocols. Anadditional computing device in communication with external device 24 maybe a networked device such as a server capable of processing informationretrieved from IMD 10 and/or PD 12.

In some examples, processing circuitry 110 may receive a signal fromsensor 100 of PD 12 via direct or indirect communication with PD 12using communication circuitry 116. Using the signal, processingcircuitry 110 may, in whole or in part, perform any of the methodsdescribed herein for detecting impingement. In some examples, processingcircuitry 110 may receive values for features of the signal during oneor more cardiac cycles rather than the motion signal, or classificationof beats as to whether or not they include impingement rather than thefeature values, and perform some portions of methods described hereinusing the received features or classification information. Features of asignal that may indicate impingement include an amount of motion (e.g.,a maximum, mean, median, derivative or rate of change, or integral)during the cardiac cycle, which may be in one or more directions otherthan the primary axis of motion of the cardiac contraction, duration ofthe signal during the heartbeat, and signal hull curve or othermorphological characterization of the signal. Features of the signalthat may indicate impingement may additionally or alternatively includethe presence of frequencies higher than those associated with movementof heart tissue during contraction. Impingement may be detected based onthe frequency of the signal by determining that a magnitude of thesignal at a particular frequency or within a particular frequency band,such as a range from about 10 Hertz (Hz) to about 100 Hz or moreparticularly from about 20 Hz to 50 Hz, satisfies, e.g., exceeds, athreshold.

FIG. 8 is a block diagram illustrating a system 140 that includes anexternal device 142, such as a server, and one or more computing devices144A-144N that are coupled to IMD 10, PD 12, and external device 24 viaa network 150, according to one example. In this example, IMD 10 usescommunication circuitry to communicate with external device 24 via afirst wireless connection and communicates with an access point 152 viaa second wireless connection. PD 12 uses communication circuitry tocommunicate with external device 24 via a first wireless connection andcommunicates with an access point 152 via a second wireless connection.IMD 10 and PD 12 communicate with each other via a shared third wirelessconnection. In the example of FIG. 8, access point 152, external device24, external device 142, and computing devices 144A-144N areinterconnected, and able to communicate with each other, through network150. In some cases, one or more of access point 152, external device 24,external device 142, and computing devices 144A-144N may be coupled tonetwork 150 through one or more wireless connections. IMD 10, PD 12,external device 24, external device 152, and computing devices 144A-144Nmay each comprise one or more processing circuitries, such as one ormore microprocessors, DSPs, ASICs, FPGAs, programmable logic circuitry,or the like, that may perform various functions and operations, such asthose described herein.

Access point 152 may comprise a device that connects to network 150 viaany of a variety of connections, such as telephone dial-up, digitalsubscriber line (DSL), or cable modem connections. In other examples,access point 152 may be coupled to network 150 through different formsof connections, including wired or wireless connections. In someexamples, access point 152 may communicate with external device 24, PD12, and/or IMD 10. Access point 152 may be co-located with patient 14(e.g., within the same room or within the same site as patient 14) ormay be remotely located from patient 14. For example, access point 152may be a home monitor located in the patient's home or is portable forcarrying with patient 14.

During operation, IMD 10 and/or PD 12 may collect, measure, and storevarious forms of diagnostic data. For example, IMD 10 and/or PD 12 maycollect EGM and motion signals, and determine different CRTconfigurations, A-V intervals, and whether impingement is occurring. Incertain cases, IMD 10 and/or PD 12 may directly analyze collecteddiagnostic data and generate any corresponding reports or alerts. Insome cases, however, IMD 10 and/or PD 12 may send diagnostic data toexternal device 24, access point 152, and/or external device 142, eitherwirelessly or via access point 152 and network 150, for remoteprocessing and analysis. For example, IMD 10 and/or PD 12 may sendexternal device 24 data that indicates the occurrence and severity ofimpingement of cardiac tissue with PD 12, such as mechanical collisionswith cardiac structures such as papillary muscles, cordae, valvestructures, or ventricular endocardium. External device 24 may generatereports or alerts after analyzing the data.

In another example, IMD 10 and/or PD 12 may provide external device 142with collected EGM and motion signal data, system integrity indications,and any other relevant physiological or system data via access point 152and network 150. External device 142 includes one or more processingcircuitries 148. In some cases, external device 142 may request suchdata, and in some cases, IMD 10 and/or PD 12 may automatically orperiodically provide such data to external device 142.

In one example, external device 142 may comprise a secure storage sitefor information that has been collected from IMD 10, PD 12, and/orexternal device 24. In this example, network 150 may comprise anInternet network; and trained professionals, such as clinicians, may usecomputing devices 144A-144N to securely access stored data on externaldevice 142. For example, the trained professionals may need to enterusernames and passwords to access the stored information on externaldevice 142. In one embodiment, external device 142 may be a MedtronicCareLink® server provided by Medtronic plc of Dublin, Ireland. In someexamples, patients may use computing devices 144 to receive dataregarding their devices and treatment.

In some examples, processing circuitry and memory of one or more ofaccess point 152, server 142, or computing devices 144, e.g., processingcircuitry 148 and memory of server 142, may be configured to providesome or all the functionality ascribed to processing circuitry andmemory of IMD 10 and/or PD 12. For example, server 142 may be configuredto receive a signal from sensor 100 of PD 12 via communication with PD12 via network 150 and one or more of access point 152 and externaldevice 234. Using the signal, processing circuitry 146 may, in whole orin part, perform any of the methods described herein including detectingimpingement based on the signal

FIGS. 9A-H illustrate example techniques for securing PD 240 to patienttissue 200 using delivery device 220. PD 240 may correspond to PDs 12 inFIGS. 1A-1C, 2, 4, and 6. PDs 12 and 240 may be examples of IMDs thatinclude a motion sensor and are configured for implantation on or withinthe heart. In some examples, delivery device 220 may be a catheter. Asan example, patient tissue 200 may be a heart tissue, such as the innerwall of the left ventricle. For simplicity, a set of only two activefixation tines 210 are shown in each of FIGS. 9A-H but more fixationtines 210 may be used.

FIG. 9A illustrates PD 240 within lumen 222 of delivery device 220.Lumen 222 holds active fixation tines 210 in a spring-loaded position inwhich distal ends 212 of active fixation tines 210 point away from PD240. Aperture 228 is positioned adjacent patient tissue 200.

FIG. 9B illustrates PD 240 shortly after a clinician remotely activatedactive fixation tines 210 using deployment element 226 by pressing onplunger (not shown, proximal end of delivery device 220). As theclinician pressed plunger, deployment element 226 pushed PD 240 distallywithin lumen 222. Once the distal ends 212 of active fixation tines 210reached aperture 228, active fixation tines 210 began to pull PD 240 outof lumen 222 via aperture 228. Distal ends 212 of active fixation tines210 then penetrated patient tissue 200. FIG. 9B illustrates activefixation tines 210 in a position after distal ends 212 of activefixation tines 210 penetrated patient tissue 200 and shortly afterbeginning the transition from a spring-loaded position to a hookedposition.

FIGS. 9B-F illustrate active fixation tines 210 as they move from aspring-loaded position in which distal ends 212 of active fixation tines210 point away from PD 240 to a hooked position in which distal ends 212of active fixation tines 210 bend back towards PD 240. FIGS. 9D-Fillustrate active fixation tines 210 in hooked positions. In FIG. 9D,distal ends 212 of active fixation tines 210 remain embedded in patienttissue 200, whereas FIGS. 9E and 9F illustrate distal ends 212 of activefixation tines 210 penetrating out of patient tissue 200.

As active fixation tines 210 pull PD 240 from lumen 222, tether 230,which is attached to delivery tool interface 216 of PD 240 is exposed,e.g., as shown in FIG. 9E. Following deployment of PD 240, a clinicianmay remotely pull PD 240 back into lumen 222 by pulling on tether 230 atthe proximal end of delivery device 220. For example, the clinician maydirect PD 240 to perform a test to evaluate a performance characteristicof electrode 214 while PD 240 is secured to patient tissue 200 as shownin FIG. 9E. If the test of PD 240 indicates inadequate performance, theclinician may decide to redeploy, e.g., move, PD 240. Pulling PD 240back into lumen 222 releases PD 240 from patient tissue 200 and returnsPD 240 to the position shown in FIG. 9A. From this position, a clinicianmay reposition PD 240 as desired and redeploy PD 240. The performancetest may include one or both of PD 240 measuring an impedance of anelectrical path including electrode 214 or determining whether pacingpulses delivered by electrode 214 capture cardiac tissue 228.

As discussed herein, PD 240 may also determine whether impingements ofPD 240 with cardiac tissue occur, e.g., during the implantation of PD240 illustrated in FIGS. 9A-9H. In some examples, PD 240 may determinewhether impingements occur while PD 240 is in the position illustratedby FIG. 9E, e.g., before, after, or concurrent with the performancetesting of electrode 214. When PD 240 is in the proposed implantposition as illustrated by FIG. 9E, a user, such as an implantingclinician or assistant, may direct PD 240 to execute the performancetests and check for impingements using external device 24 or anothercomputing device. External device 24 or another computing device mayprovide the user an indication of the result of such tests, e.g., anindication of whether impingement occurred, or a degree of impingement.The user may determine whether to reposition PD 240 based on theindication.

As shown in FIG. 9F, once PD 240 is secured to patient tissue 200 in thedesired position, the clinician may release PD 240 from tether 230. Forexample, the clinician may sever tether 230 at the proximal end ofdelivery device 220 and remove tether 230 from delivery tool interface216 by pulling on one of the severed ends of tether 230. As shown inFIG. 9G, once PD 240 is released from tether 230, the clinician mayremove delivery device 220, leaving PD 240 secured to patient tissue200. As shown in FIG. 9H, active fixation tines 210 may continue tomigrate to a lower potential energy hooked position over time. Any ofthe hooked positions of active fixation tines 210 as shown in FIGS. 9D-Gmay be sufficient to adequately secure PD 240 to patient tissue 200.

While the techniques of FIGS. 9A-H are illustrated with respect to PD240, the techniques may also be applied to a different IMD, such as amedical lead including a set of active fixation tines like medicalleads. For example, such a medical lead may extend through a catheterduring an implantation procedure. As such, deploying a medical lead maynot require a separate deployment element within the catheter. Instead,pushing on the medical lead at the proximal end of the catheter mayinitiate deployment of a set of active fixation tines at the distal endof the medical lead by pushing the active fixation tines attached to thedistal end of the medical lead out of the distal end of the catheter.Similarly, retracting a medical lead for redeployment may not require atether, but may instead involve pulling on the medical lead at theproximal end of the catheter.

FIG. 10 is a flow diagram illustrating an example process for monitoringfor impingement of an IMD within a patient including while implantingthe IMD, in accordance with one or more aspects of this disclosure. Moreparticularly, FIG. 10 illustrates method 300 in which PD 12 and/orprocessing circuitry of other devices of a medical device system 8,monitors for impingement of PD 12, e.g., with cardiac tissue present ina patient.

Method 300 begins during implantation of PD 12 or after PD 12 isimplanted into the patient. Method 300 is not limited to the examples inwhich PD 12 is affixed to an inner wall of the left ventricle. Forexample, the fixation mechanism of PD 12 may be attached to the RVinstead of the LV. Additionally, PD 12 may be placed on an outer wall ofthe LV and/or RV. Furthermore, although described in the context of anexample in which PD 12 and processing circuitry 90 of PD 12 perform anumber of the functions illustrated in the example of FIG. 10, in otherexamples one or more of these functions may be performed by one or moreother devices that communicate with PD 12, such as IMD 10, externaldevice 24, external device 142, or computing devices 144, e.g., by theprocessing circuitry of such devices.

According to example method 300, a catheter, which may include PD 12within its lumen, is positioned to a location within the patientadjacent a patient tissue, such as a LV (302). Next, PD 12 is deployedfrom the catheter to the location within the patient, such as LV (304).For example, the clinician may push on the plunger (e.g., as illustratedwith respect to FIG. 9B-9E) to deploy PD 12. The clinician and/orprocessing circuitry may then evaluate whether PD 12 is adequatelyfixated and positioned within the patient.

The evaluation may include determining whether a level of impingementbetween PD 12 and cardiac tissue or other structures, such as another PDor other IMD, or a component of PD 12 or another IMD, is acceptable(306). In order to determine whether there is an acceptable level ofimpingement, a motion signal may be received by processing circuitry 90of PD 12 from sensor 100, which may be an accelerometer or gyroscope, asexamples. Again, as discussed herein, the motion signal may additionallyor alternatively be received by processing circuitry of other devices,including but not limited to IMD 10, external device 24, external device142, and computing devices 144.

In some examples, the presence of impingement, e.g., a mechanicalcollision, may be indicated by the presence of a frequency component inthe motion signal during systolic motion of the heartbeat, e.g., themagnitude of the frequency component exceeding or otherwise meeting athreshold. In some examples, impingement may be detected by identifyingmotion in a direction other than a primary axis of motion during theheartbeat and determining that the motion meets one or more impingementcriteria. The primary axis of motion may be a primary axis of systolicmotion, and the motion in the direction other than the primary axismeeting the one or more impingement criteria may include an amount orvelocity of the motion exceeding (or otherwise meeting) a threshold.

In the event that the impingement is determined to be unacceptable (NOof 306), the clinician may pull tether to recapture PD 12 (308). Theclinician may either reposition PD 12 or replace PD 12 with another PDat a location better suited for the implantation. The process may startover by positioning a catheter adjacent a patient tissue at the newlocation (302). If PD 12 is adequately positioned within the patient(YES of 306), which may include an acceptable level of impingement andsatisfaction of other acceptance criteria, e.g., adequate pacing capturethreshold and subthreshold impedance, the clinician fully releases IMD10 from the tether (312). Then, the clinician withdraws the deploymentdevice from the patient, leaving IMD 10 secured within the patient(314).

Although the example method of FIG. 10 illustrates impingement detectionas being performed during implantation of PD 12, impingement detectionmay be performed at any time, such as after PD 12 has been implanted.For example, impingement detection may be performed in response to acommand from external device 24, server 142, or computing device 144, oron a periodic basis. The periodic basis may be a beat-to-beat basis, orless frequently, such as according to a X of Y cycle or X cycle everytime period schedule, hourly, or daily. For example, impingementdetection may be performed for one cardiac cycle out of every tencycles, or for one cycle every minute.

Further, although described herein in the context of detectingimpingement of an IMD with another structure, processing circuitry mayevaluate similar features of a motion signal from a motion sensor, suchas a three-dimensional accelerometer or gyroscope, to assess properfixation the IMD, e.g., a PD. For example, if the engagement of one ormore fixation elements with patient tissue is incomplete, a PD may movein unexpected ways during the cardiac cycle, e.g., flopping around ortwisting—motions that would not normally occur with adequate fixation.The processing circuitry may classify the motion as improper fixationbased on a frequency or amount of the motion, e.g., in a direction otherthan the primary axis of cardiac motion during contraction.

FIG. 11 is a flow diagram illustrating an example process fordetermining whether impingement is occurring based on an evaluation ofone or more features of the signal from a motion sensor 100 of PD 12during a cardiac beat. Although described in the context of an examplein which PD 12 and processing circuitry 90 of PD 12 perform a number ofthe functions illustrated in the example of FIG. 11, in other examplesone or more of these functions may be performed by one or more otherdevices that communicate with PD 12, such as IMD 10, external device 24,external device 142, or computing devices 144, e.g., by the processingcircuitry of such devices.

FIG. 11 illustrates an example method for testing whether an impingementshould be indicated while using the techniques described herein. Thevalue(s) of the features that indicate whether impingement criteria havebeen met include, e.g., the magnitude of the motion signal at a certainfrequency or within a certain frequency band and the magnitude or amountor velocity of motion in a direction other than the primary axis ofmotion attributable to the cardiac contraction. The example method ofFIG. 11 may be performed during implantation or shortly after implant ofPD 12, at a clinic visit, automatically in response to a remote command,and/or on a periodic basis.

According to the example method 400 of FIG. 11, the motion signal isreceived by processing circuitry 90 of PD 12 from sensor 100, which maybe an accelerometer or gyroscope, as examples (402). Again, as discussedherein, the motion signal may be received by processing circuitry ofother devices, including but not limited to IMD 10, external device 24,external device 142, and computing devices 144. The processing circuitryat such devices can receive the motion signal. Further, the motionsignal may be more than one motion signal, e.g., a signal for each of atwo or more axis of a multi-axis accelerometer, in some examples.

Processing circuitry 90 identifies a cardiac beat within the motionsignal (404) and identifies features of the signal within the beat(406). Features of the beat used to measure impingement may include, forexample, an amount or magnitude of motion, e.g., velocity ordisplacement, which may be in a direction other than the primary axis,such as in a plane orthogonal to the primary axis of motion during thebeat. In some examples, the primary axis of motion comprises a primaryaxis of systolic motion, and the motion in the direction other than theprimary axis meeting the one or more impingement criteria includes anamount of the motion exceeding a threshold. In some examples, the amountof motion is characterized by a sum of the distances, at various pointsin time during the contraction, from a point of origin of thecontraction, or by a maximum distance or another one or more distancesfrom the point of origin.

In addition, features of the beat used to measure impingement may alsoinclude, for example, a frequency of the signal during the beat that isatypical for cardiac motion. In some examples, identifying one of theimpingements based on the frequency meeting one or more impingementcriteria includes a magnitude of frequency component in the signalduring systolic motion of the heartbeat exceeding a threshold. Examplefeatures of a signal used to measure impingement are illustrated anddescribed in further detail with respect to FIGS. 12A-14.

Processing circuitry 90 compares the identified features of the beat toone or more criteria, which may include comparison to one or moretemplate or threshold values of the feature, as described herein (408).Based on the comparison to one or more templates or threshold values ofthe feature, processing circuitry 90 may indicate impingement for thebeat (410). If impingement is detected (or meets a threshold number orpercentage of beats exhibiting impingement (YES of 410), processingcircuitry 90 may indicate impingement (412). If impingement is notdetected (or does not meet the threshold) (NO of 410), the process mayreturn to the beginning of the method at step 404 and identify the nextbeat.

As described above, the motion signal, and consequently the features ofthe beat indicative of impingement, may vary depending on the posture oractivity level of the patient. In some examples, processing circuitry 90may identify the posture or activity level of the patient and adjust oneor more aspects of impingement detection to compensate for theposture-based variations. For example, processing circuitry 90 mayadjust one or both of the identified features of the signal or theimpingement criteria, e.g., according to a function or lookup table,based on the identified posture or activity level.

Although the example techniques of FIGS. 10 and 11 are describedprimarily in the context of PD 12 implanted in the left-ventricle, otherexample medical devices may implement the techniques to evaluate theimpingement of cardiac structures. In some examples, an extracardiacpacemaker may deliver ventricular pacing through electrodes of one ormore leads. The pacemaker may also be coupled to a motion sensor, e.g.,by a lead or wirelessly, to receive a motion signal during theheartbeat.

FIGS. 12A and 12B show actual human three-dimensional accelerometer data(in units where 1=the gravitational force of Earth) from a pacing devicefor a subject with suspected impingement during cardiac contraction.FIG. 12A is a plot illustrating normal sinus rhythm (NSR) emphasizingmotion of an IMD, e.g., PD 12, during cardiac contraction, in accordancewith one or more aspects of this disclosure. FIG. 12B is a plotillustrating the motion of the IMD with the axes rotated such that thesystolic excursion (primary axis) is minimized and the motion orthogonalto the primary axis is emphasized, in accordance with one or moreaspects of this disclosure. FIGS. 12A and 12B each show one cardiaccycle. In FIG. 12A, a diastole portion of the cardiac cycle isidentified with a solid line and reference item number 510A, a systoleportion of the cardiac cycle is identified with a dotted line andreference item number 520A, and a high frequency artifact is identifiedwith a dashed line and reference item number 530A.

In FIG. 12B, the axes have been rotated such that the systolic excursion(primary axis) is minimized. The image thus emphasizes the accelerometercomponents that are orthogonal to the primary systolic contraction. InFIG. 12B, a diastole portion of the cardiac cycle is identified with asolid line and reference number 510B, a systole portion of the cardiaccycle is identified with a dotted line and reference item number 520B,and a high frequency artifact is identified with a dashed line andreference item number 530B.

Synchronous contraction without impingement may result in predominantacceleration of PD 12 (with physiologic frequency content) in a singledirection during systole. By determining an amount or velocity of motionin a direction other than the primary axis of systolic motion, such asin a plane orthogonal to the axis, processing circuitry, e.g.,processing circuitry 90 of PD 12, may detect impingement. In someexamples, the amount of motion may be a sum of distances from an originat various points during the systole portion of the cardiac cycle. Theamount of motion not associated with the primary movement of the heartduring systole may be used, according to the techniques of thisdisclosure to discriminate beats with impingement.

High frequency content in the acceleration signal may also indicate animpingement, such as a mechanical collision. Processing circuitry 90 maydetermine the magnitude of the signal at a certain frequency, or withina certain frequency band (such as above a frequency threshold).Processing circuitry 90 may detect impingement during a cardiac beatbased on the magnitude meeting a magnitude threshold.

FIGS. 13A and 13B are plots of motion sensor data illustrating motion ofthe IMD, including the frequency of the motion during systole, inaccordance with one or more aspects of this disclosure. FIGS. 13C and13D are plots of motion sensor data with axes transformed illustratingmotion of the IMD in the two axes of the plane that are orthogonal tothe primary systolic axis during cardiac contraction, in accordance withone or more aspects of this disclosure. FIGS. 13A and 13C are forSubject 1 who is suspected to have normal motion of the IMD duringsystole. FIGS. 13B and 13D are for Subject 2 who is suspected to have acollision of the IMD during systole. For FIGS. 13A-D, the plots are for4 ms samples where 0 is equal to the start of the R-wave, and thesubjects 1 and 2 display a narrow intrinsic QRS and have devicesimplanted in the apex. For FIG. 13A, 610A, 620A, and 630A representthree axes of the same cardiac contraction, and similarly for FIG. 13B,610B, 620B, and 630B represent three axes of the same cardiaccontraction. For FIGS. 13B and 13D, 600B and 600D represent the highfrequency artifact.

FIG. 13A shows suspected normal motion of the IMD during systole ashaving predominantly low frequency and in a single direction. Incontrast, FIG. 13B shows the suspected collision motion of the IMDduring systole as having a high frequency section 600B, which suggestsmechanical collision. In contrast to FIG. 13C, FIG. 13D displays moreenergy in axes orthogonal to the primary axis of motion during systole,in particular section 600D. The relatively greater amount of orthogonalacceleration may indicate mechanical collision or dyssynchrony.

FIG. 14 is a conceptual plot of motion of the IMD during cardiaccontraction illustrating example features of the motion signal, inaccordance with one or more aspects of this disclosure. FIG. 14 shows aplot illustrating an example of one portion 700 of the signal of acardiac cycle looking down the primary axis of motion during systole.Vectors 720A, 720B, and 720C (collectively “vectors 720”) illustratemotion or displacement from an origin of the contraction 710 indirections other than along the primary axis of motion during systole,e.g., motion in a plane orthogonal to the primary axis, such as due toimpingement. Although three vectors 720 are illustrated in FIG. 14,processing circuitry may determine more or fewer vectors 720 todetermine impingement as described herein. FIG. 14 shows the beat havinga large motion during systole with a vector 720A from origin of thecontraction 710. The amount of motion in a direction other than theprimary axis of motion, e.g., the maximum, sum, rate of change, or meanof vectors 720, may be used to determine whether impingement hasoccurred and/or a degree of impingement. Vectors, such as vectors 720Band 720C, with short distances to origin of the contraction 710 may beused to indicate the absence of impingement. While vectors, such asvector 720A, with large distances origin of the contraction 710 mayindicate impingement.

The disclosure also contemplates computer-readable storage mediacomprising instructions to cause a processor to perform any of thefunctions and techniques described herein. The computer-readable storagemedia may take the example form of any volatile, non-volatile, magnetic,optical, or electrical media, such as a RAM, ROM, NVRAM, EEPROM, orflash memory. The computer-readable storage media may be referred to asnon-transitory. A programmer, such as patient programmer or clinicianprogrammer, or other computing device may also contain a more portableremovable memory type to enable easy data transfer or offline dataanalysis.

In addition, it should be noted that system described herein may not belimited to treatment of a human patient. In alternative examples, thesystem may be implemented in non-human patients, e.g., primates,canines, equines, pigs, and felines. These other animals may undergoclinical or research therapies that may benefit from the subject matterof this disclosure.

The techniques described in this disclosure, including those attributedto IMD 10, PD 12, external device 24, and various constituentcomponents, may be implemented, at least in part, in hardware, software,firmware or any combination thereof. For example, various aspects of thetechniques may be implemented within one or more processors, includingone or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalentintegrated or discrete logic circuitry, as well as any combinations ofsuch components, embodied in programmers, such as physician or patientprogrammers, stimulators, remote servers, or other devices. The term“processor” or “processing circuitry” may generally refer to any of theforegoing logic circuitry, alone or in combination with other logiccircuitry, or any other equivalent circuitry.

Such hardware, software, firmware may be implemented within the samedevice or within separate devices to support the various operations andfunctions described in this disclosure. For example, any of thetechniques or processes described herein may be performed within onedevice or at least partially distributed amongst two or more devices,such as between IMD 10, PD 12, external device 24. In addition, any ofthe described units, modules or components may be implemented togetheror separately as discrete but interoperable logic devices. Depiction ofdifferent features as modules or units is intended to highlightdifferent functional aspects and does not necessarily imply that suchmodules or units must be realized by separate hardware or softwarecomponents. Rather, functionality associated with one or more modules orunits may be performed by separate hardware or software components, orintegrated within common or separate hardware or software components.

The techniques described in this disclosure may also be embodied orencoded in an article of manufacture including a computer-readablestorage medium encoded with instructions. Instructions embedded orencoded in an article of manufacture including a computer-readablestorage medium encoded, may cause one or more programmable processors,or other processors, to implement one or more of the techniquesdescribed herein, such as when instructions included or encoded in thecomputer-readable storage medium are executed by the one or moreprocessors. Example computer-readable storage media may include randomaccess memory (RAM), read only memory (ROM), programmable read onlymemory (PROM), erasable programmable read only memory (EPROM),electronically erasable programmable read only memory (EEPROM), flashmemory, a hard disk, a compact disc ROM (CD-ROM), a floppy disk, acassette, magnetic media, optical media, or any other computer readablestorage devices or tangible computer readable media.

Various examples have been described. However, other examples arecontemplated. For example, although primarily described in the contextof a system that includes a single PD and another IMD, e.g., asubcutaneous IMD, used to control CRT pacing by the PD, the techniquesdescribed herein may be embodied in any of a variety of systems. Asexamples, the techniques described herein may be implemented in systemsthat include one or more PDs, e.g., for bradycardia pacing and/or ATP,systems that do not include another IMD, or systems that include anyother implantable or external medical device, such as another,implantable or external pacemaker, cardioverter, defibrillator,neurostimulator, pump, or ventricular assist device. Any such devicesmay provide off-board processing of a motion signal from an IMD todetect impingement of the IMD. Additionally, although described in thecontext of the motion signal being additionally used to evaluatecontractions for determining whether pace beats achieve fusion, otheruses of the motion signal may include determining activity, posture, orsleep of the patient, evaluating cardiac contractions or patient postureor activity to determine whether to deliver an antitachyarrhythmia shockin response to electrogram-based tachyarrhythmia detection, orcontrolling the speed or other parameters of a ventricular assistdevice. These and other examples are within the scope of the followingclaims.

What is claimed is:
 1. A method for evaluating implantation of animplantable medical device configured for at least one of deliveringcardiac therapy or cardiac sensing, wherein the implantable medicaldevice is attached by a fixation element to a heart of a patient, themethod comprising: producing, by a sensor, a signal that is indicativeof a motion of the implantable medical device; and identifying one ormore impingements between a housing of the implantable medical deviceand another structure based on the signal from the sensor.
 2. The methodof claim 1, wherein the implantable medical device comprises a pacemakerconfigured to deliver cardiac pacing to the heart.
 3. The method ofclaim 2, wherein the implantable medical device is configured to delivercardiac resynchronization therapy to at least one ventricle of theheart.
 4. The method of claim 1, wherein the implantable medical deviceis implanted within the heart.
 5. The method of claim 1, whereinidentifying the one or more impingements comprises identifying, byprocessing circuitry of the implantable medical device, the one or moreimpingements based on the signal from the sensor.
 6. The method of claim1, wherein identifying the one or more impingements comprisesidentifying one or more collisions between the housing and the otherstructure based on the signal from the sensor.
 7. The method of claim 1,wherein identifying the one or more impingements comprises: identifyinga heartbeat; and identifying one of the impingements during theheartbeat.
 8. The method of claim 7, wherein identifying the one or moreimpingements comprises: identifying a frequency of the signal during theheartbeat; and identifying the one of the impingements based on thefrequency meeting one or more impingement criteria.
 9. The method ofclaim 8, wherein the frequency meeting the one or more impingementcriteria includes a frequency component in the signal during systolicmotion of the heartbeat exceeding a threshold value.
 10. The method ofclaim 7, wherein identifying the one or more impingements comprises:identifying motion in a direction other than a primary axis of motionduring the heartbeat; and identifying the one of the impingements basedon the motion in the direction other than the primary axis meeting oneor more impingement criteria.
 11. The method of claim 10, wherein theprimary axis of motion comprises a primary axis of systolic motion, andthe motion in the direction other than the primary axis meeting the oneor more impingement criteria includes an amount of the motion exceedinga threshold value.
 12. The method of claim 1, wherein the sensorcomprises a three-dimensional accelerometer.
 13. The method of claim 1,wherein identifying the one or more impingements comprises indicating toa user to reposition the implantable medical device.
 14. The method ofclaim 13, wherein repositioning the implantable medical device includesdetaching the fixation element from the heart of the patient andattaching the implantable medical device at another location on theheart of the patient.
 15. The method of claim 1, wherein identifying theone or more impingements between the housing of the implantable medicaldevice and the other structure comprises identifying one or moreimpingements between the housing and a cardiac tissue.
 16. A system forevaluating implantation of an implantable medical device configured forat least one of delivering cardiac therapy or cardiac sensing, whereinthe implantable medical device is attached by a fixation element to aheart of a patient, the system comprising: means for producing, by asensor, a signal that is indicative of a motion of the implantablemedical device; and means for identifying one or more impingementsbetween a housing of the implantable medical device and anotherstructure based on the signal from the sensor.
 17. A computer-readablestorage medium comprising instructions that, when executed by processingcircuitry of a medical device system for evaluating implantation of animplantable medical device configured for at least one of deliveringcardiac therapy or cardiac sensing, wherein the implantable medicaldevice is attached by a fixation element to a heart of a patient, causethe processing circuitry to: produce, by a sensor, a signal that isindicative of a motion of the implantable medical device; and identifyone or more impingements between a housing of the implantable medicaldevice and another structure based on the signal from the sensor.